The Melbourne Infant Study: BCG for Allergy and Infection Reduction (MIS BAIR) study is a randomised controlled trial (RCT) to assess the effect of neonatal BCG (tuberculosis) vaccination on clinical allergy and infection outcomes over the first five years of life. The study is based on the hypothesis that the heterologous effects of BCG on innate immunity and the cellular immune response has a beneficial effect on the developing immune system. The study has both clinical and laboratory components.

The clinical outcome measures are respiratory infections, eczema and allergic sensitisation (measured by skin prick test). A combination of medical records and parent-completed online questionnaires are used to collect extensive and detailed antenatal, perinatal and postnatal data. The laboratory component comprises an extensive collection of biosamples for future immunological and molecular studies.

MIS BAIR is an open randomised controlled trial (RCT) that will assess the effect of neonatal BCG vaccination on clinical allergy and infection outcomes in infants in Melbourne (Australia).

Sampling frame

Pregnant women attending participating antenatal clinics in Melbourne and Geelong were approached to participate (Mercy Hospital for Women, Melbourne; Werribee Mercy Hospital; University Hospital Geelong; St John of God Geelong Hospital). Media releases were also used to inform pregnant women about the study. Pregnant women or mothers interested in joining the study, but not being cared for at a study maternity site, were enrolled through the Royal Children’s Hospital, Melbourne. Eligible infants were: less than 10 days old, birth weight > 1500 g, and born no earlier than 8 weeks before estimated date of delivery.